DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-41 were originally filed February 26, 2024.
The amendment received January 31, 2025 canceled claims 1, 6, 9, 13, 15, 17, 21, 23-28, 31, 32, and 34-39 and amended claims 2-5, 7, 8, 10-12, 14, 16, 18-20, 22, 29, 30, 33, 40, and 41.
The amendment received September 16, 2026 changed the status identifiers only.
Claims 2-5, 7, 8, 10-12, 14, 16, 18-20, 22, 29, 30, 33, 40, and 41 are currently pending.
Claims 2-5, 7, 14, 16, 20, 22, and 29 are currently under consideration.
Election/Restrictions
Applicant’s election of Group I (claims 2-5, 7, 8, 10-12, 14, 16, 18-20, 22, 29, and 30) in the reply filed on September 16, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 33, 40, and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 16, 2026.
Applicant's election with traverse of chenodeoxycholic acid (CDCA), hnRNPA1 M9 NLS (SEQ ID NO: 4), buffered solution, at least 20 mg/ml, dimer, one complete hydrogel structure, dimerization of the steroid acid-peptide conjugate, and N,N-diisopropyethylamine (DIPEA) as the species in the reply filed on September 16, 2026 is acknowledged. The traversal is on the grounds that the examiner of record has not filled in the required text for form paragraph 18.20 and has not included at least one of form paragraphs 18.07.01-18.07.03. Applicant’s representative also stated that species were not adequately identified. Applicant’s representative also stated that claims 2 and 30 are both hydrogels and do not have different species. Applicant’s representative also states that they could not frame a responsive election without knowing what is intended (page 9, lines 9-10). This is not found persuasive because the required text for form paragraph 18.20 was filled out by the examiner of record (see pages 4-6 of the Restriction Requirement mailed July 16, 2026) and form paragraph 18.07.02 was included (see page 6 of the Restriction Requirement mailed July 16, 2026). This is not found persuasive since claims with species were identified where possible. In addition, applicant’s representative should be well aware of what is included in the specification, particularly a short 12 page specification. It is respectfully noted that claim 30 is drawn to liquid droplets (i.e. a species of hydrogel). Applicant’s representative should have called the examiner of record if they required additional assistance understanding the species requirement. In addition, it appears that applicant’s representative did understand the species requirement because the response is complete regarding the election of species.
Please note: SEQ ID NO: 4 and DIPEA are not part of the present claims and, therefore, are not required to be part of any rejection of record.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8, 10-12, 18, 19, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 16, 2026.
Priority
The present application is a 371 (National Stage) of PCT/CA2022/051298 filed August 26, 2022 which claims the benefit of 63/260,648 filed August 27, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 18, 2024; January 31, 2025; and September 16, 2026 are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
See page 8, line 3.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Objections
Claim 2 is objected to because of the following informalities: the claim should be clarified regarding what is incubated (see line 4). Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the spacing should be corrected (see line 5). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
With regard to the written description requirement, the attention of the Applicant is directed to The Court of Appeals for the Federal Circuit which held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)] (the case is referred to herein as “Lilly”).
Additionally, it is noted that written description is legally distinct from enablement: “Although the two concepts are entwined, they are distinct and each is evaluated under separate legal criteria. The written description requirement, a question of fact, ensures that the inventor conveys to others that he or she had possession of the claimed invention; whereas, the enablement requirement, a question of law, ensures that the inventor conveys to others how to make and use the claimed invention.” See 1242 OG 169 (January 30, 2001) citing University of California v. Eli Lilly & Co.
Although directed to DNA compounds, this Eli Lilly holding would be deemed to be applicable to any compound or a generic of compounds; which requires a representative sample of compounds and/or a showing of sufficient identifying characteristics; to demonstrate possession of the compound or generic(s). In this regard, applicant is further referred to University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997); “Guidelines for Examination of Patent Applications Under the 35 USC 112, first paragraph, ‘Written Description’ Requirement” published in 1242 OG 168-178 (January 30, 2001); and Univ. Of Rochester v G. D. Searle and Co. 249 F. Supp. 2d 216 (W.D.N.Y. 2003) affirmed by the CAFC on February 13, 2004 (03-1304) publication pending.
Additionally, Lilly sets forth a two part test for written description:
A description of a genus of cDNA’s may be achieved by means of a recitation of:
a representative number of cDNA’s, defined by nucleotide sequence, falling within the scope of the genus OR of a recitation of structural features common to the members of the genus.
See Regents of the University of California v. Eli Lilly & Co. 119 F.3d 1559 (Fed. Cir. 1997) at 1569.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Additionally, Cf. University of Rochester v G.D. Searle & Co., Inc., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., No. 03-1304, 2004 WL 260813 (Fed. Cir., Feb. 13, 2004) held that:
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
The present claims are drawn to a method of forming/producing a hydrogel, the method comprising providing a steroid acid-peptide conjugate powder; resuspending/dissolving the steroid acid-peptide conjugate powder in a solvent at a concentration sufficient to enable hydrogel formation; and incubating until a hydrogel is formed. The claims do not limit the steroid acid or the peptide. Therefore, the claims are drawn to any steroid acid or peptide regardless of the intended function of forming a hydrogel.
In the present instance, the specification discloses only limited examples that are not representative of the claimed genus of any steroid acid or any peptide; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. The instant claims define the steroid acid and peptide by the functional limitation of enable hydrogel formation. The claimed steroid acid and peptide are only defined by functional properties (e.g. hydrogel formation). The CAFC held that a functional definition is insufficient to adequately describe a product, therefore, an adequate written description not based on a functional definition is necessary.
The Examiner further notes the present claims stated by Applicant are broader in scope that those that were held to be impermissible in Lilly because, unlike Lilly, Applicants’ claims encompass a vast number of steroid acids and peptides. Here, the Applicant claims a steroid acid-peptide conjugate. The scope of these claims include a vast number of steroid acids and peptide sequences because there is not a single claim that refers to a specific combination of steroid acid-peptide conjugate which forms a hydrogel. Furthermore, the specification and claims do not place any limit on the number of components, the types of components, or the manner in which the components might be connected to achieve a hydrogel. Therefore, Applicants are using an inadequately described steroid acids and peptides to inadequately describe the claimed hydrogel. In addition, the “sufficient to enable hydrogel formation” language further exacerbates this problem because the conditions under which the hydrogel forms are not specified. Consequently, there is no teaching that would allow a person of skill in the art to determine a priori that the Applicant was in possession of the full scope of the claimed invention at the time of filing because there is no common structural attributes that can link together all of the claimed steroid acids and peptides which form hydrogels.
While the general knowledge and level of skill in the art for making hydrogels is high, this knowledge and level of skill does not supplement the omitted description because specific, not general, guidance is needed for the steroid acids and peptides which can form hydrogels. Since the disclosure fails to describe the common attributes or characteristics that identify all of the members of the genus or even a substantial portion thereof, and because the genus is vast and highly variant, the limited examples in the specification (please refer to Examples at pages 9-11) are insufficient to teach the entire genus. Results are provided for LCA-SEQ ID NO: 4 (i.e. lithocholic acid-hnRNPA1 M9 NLS) and hnRNPA1 conjugated to CA, GCDCA, GDCA, and GUDCA. However, the conditions, concentrations, and timing for hydrogel formation are different. In addition, some steroid acid-peptide conjugates did not form hydrogels (i.e. PQBP-1 and GWG-SV40; Figures 5 and 6; page 11, lines 3-5). Furthermore, not all data is provided (see page 11, lines 2 and 9). The specification at page 11, lines 14-16 reads “These data demonstrate the surprising result that different steroid acid-hnRNAA1 NLS monomer conjugates spontaneously form a hydrogel when dissolved in various solvents at different temperatures and concentrations”. CA-NLS1 RPS17 was not observed to form a hydrogel in its monomer form, yet was able to form a hydrogel in its dimerized form in multiple solvents (see Figure 9; page 11, lines 24-25). CA-mellitin (SEQ ID NO: 16) was not observed to form a hydrogel in its monomer form, yet was able to form a hydrogel in its dimerized form in multiple solvents (see Figure 12; page 11, lines 30-34).
The specification discloses only limited examples that are not representative of the claimed genus of a steroid acid-peptide conjugate which forms a hydrogel; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. Therefore, the teachings in the specification are general teachings relating without guidance as to the individual components of the product. In addition, there are numerous steroid acid-peptide conjugates that could be employed in the invention with little direction or guidance for one of skill in the art to practice the claimed invention. The expedient statements in the specification do not relate to an adequate disclosure or how to make and use the claimed invention. Consequently, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to adequately describe the vast genus. Thus, Applicant does not appear to be in possession of the claimed genus.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear under what concentration is sufficient to enable hydrogel formation. In addition, it is unclear if incubation is at room temperature or requires a different temperature.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation at least 7, and the claim also recites at least 8, 9, 10, 11, 12, etc. which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation “comprises”, and the claim also recites “is” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “comprises”, and the claim also recites “is” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitation “comprises”, and the claim also recites “is” (see lines 1 and 2) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the scope of the present claim. For example, it is unclear if “a portion of the NLS thereof” is referring to all members of the Markush group or not (i.e. multiple NLS are disclosed in the claim – see lines 2-8).
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “comprises”, and the claim also recites “is” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the scope of the present claim. For example, it is unclear what “a portion” is referring to (see line 2).
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 22 recites the broad recitation “comprises”, and the claim also recites “is” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 29 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 29 recites the broad recitation at least 5, and the claim also recites at least 6, 7, 8, 9, etc. which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 5, 7, 20, 22, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
For present claims 2, 5, 7, 20, 22, and 29, Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
For present claims 2, 5, 7, 20, 22, and 29, Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. bile acid and peptide hydrogels; bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. nonconjugated bile acid and peptide) for another (i.e. conjugated bile acid and peptide) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing bile acid and peptide conjugates to form a hydrogel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020; Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719); and Lin et al., 2015, Formation and Maturation of Phase Separated Liquid Droplets by RNA Binding Proteins, Mol Cell, 60(2): 208-219.
For present claims 2-5, 7, 14, 16, 20, 22, and 29, Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
For present claims 2-5, 7, 14, 16, 20, 22, and 29, Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
For present claims 2-5, 7, 14, 16, 20, 22, and 29, Lin et al. teach that hnRNPA1 forms liquid droplets (please refer to the entire specification particularly the abstract; Experimental Procedures).
All the claimed elements were known in the prior art (i.e. bile acid and peptide hydrogels; bile acid-peptide conjugates; hnRNPA1 forming liquid droplets) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel; strengthening of hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel; strengthening of hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. nonconjugated bile acid and peptide; genus of peptide) for another (i.e. conjugated bile acid and peptide; species of hnRNPA1) would have yielded predictable results (i.e. formation of a hydrogel with hnRNPA1) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing bile acid and peptide conjugates to form a hydrogel; hnRNPA1 forming liquid droplets) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-5, 7, 14, 16, 20, 22, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61-74 of copending Application No. 19/141,627 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
Copending Application No. 19/141,627 claims steroid acid-peptide conjugates wherein the peptide is an NLS including hnRNPA1 M9 and the steroid acid is CA, CDCA, DCA, LCA, etc.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 2-5, 7, 14, 16, 20, 22, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7-11, 16, 18, 19, 22, and 42-49 of copending Application No. 18/717,506 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
Copending Application No. 18/717,506 claims a hydrogel comprising a steroid acid-peptide conjugates wherein the peptide is an NLS including hnRNPA1 M9 and the steroid acid is CA, CDCA, DCA, LCA, etc.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 2-5, 7, 14, 16, 20, 22, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/545,008 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
Copending Application No. 18/545,008 claims steroid acid-peptide conjugates wherein the peptide is an NLS including hnRNPA1 M9 and the steroid acid is CA, CDCA, DCA, LCA, etc.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 2-5, 7, 14, 16, 20, 22, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 25, 27, 29-31, and 33-40 of copending Application No. 18/046,718 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
Copending Application No. 18/046,718 claims steroid acid-peptide conjugates wherein the peptide is an NLS including hnRNP and the steroid acid is CA, CDCA, DCA, LCA, etc.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,150,989 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
U.S. Patent No. 12,150,989 claims steroid acid-peptide conjugates comprising a NLS including hnRNPA1 M9.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,291,717 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
U.S. Patent No. 11,291,717 claims steroid acid-peptide conjugates comprising a NLS including hnRNPA1 M9 and the steroid acid is a bile acid including CA, CDCA, DCA, LCA, etc.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,352,437 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020; Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719); and Lin et al., 2015, Formation and Maturation of Phase Separated Liquid Droplets by RNA Binding Proteins, Mol Cell, 60(2): 208-219.
U.S. Patent No. 11,352,437 claims cholic acid-NLS conjugates.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
Lin et al. teach that hnRNPA1 forms liquid droplets (please refer to the entire specification particularly the abstract; Experimental Procedures).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates; NLS of SV-40 large T-antigen) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel; NLS of hnRNPA1) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product; NLS of SV-40 large T-antigen) for another (i.e. method of making a hydrogel with the product; NLS of hnRNPA1) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,076,396 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
U.S. Patent No. 12,076,396 claims steroid acid-peptide conjugates comprising a NLS including hnRNPA1 M9 and the steroid acid is a bile acid including CA, CDCA, DCA, LCA, etc.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,612,651 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
U.S. Patent No. 11,612,651 claims steroid acid-peptide conjugates comprising a NLS including hnRNP M and the steroid acid is a bile acid including CA, CDCA, DCA, LCA, etc.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,890,350 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
U.S. Patent No. 11,890,350 claims steroid acid-peptide conjugates comprising a NLS including hnRNP M and the steroid acid is a bile acid including CA, CDCA, DCA, LCA, etc.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,233,130 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
U.S. Patent No. 12,233,130 claims steroid acid-peptide conjugates comprising a NLS including hnRNPA1 M9 and the steroid acid is a bile acid including CA, CDCA, DCA, LCA, etc.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 2-5, 7, 14, 16, 20, 22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,350,346 in view of Van der Poll et al. U.S. Patent Application Publication 2020/0114010 published April 16, 2020 and Zhang et al., 2016, Supermolecular hydrogelation with bile acid derivatives: structures, properties and applications, Journal of Materials Chemistry B, 4: 7506-7520 (as evidenced by citation 111; Maity et al., 2015, Hydrogelation of bile acid-peptide conjugates and in situ synthesis of silver and gold nanoparticles in the hydrogel matrix, RSC Advances, 5: 90712-90719).
U.S. Patent No. 12,350,346 claims steroid acid-peptide conjugates comprising a NLS and the steroid acid is a bile acid including CA, CDCA, DCA, LCA, etc.
Van der Poll et al. teach a method of forming/producing a hydrogel comprising providing a steroid acid/gelator including glycocholic acid (GCA) and a peptide in powder form at greater than 3% weight/volume, resuspending/dissolving the steroid acid and peptide in a solvent including a buffered solvent, and incubating to form a hydrogel (please refer to the entire specification particularly the abstract; paragraphs 2, 4, 11, 12, 16, 27-31, 33, 44, 49, 54, 58, 61-70, 73, 82, 94-98, 105-115).
Zhang et al. teach bile acid-peptide conjugates which can form hydrogels wherein the bile acid is cholic acid (CA), deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), lithocholic acid (LCA), ursodeoxycholic acid (UDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), and taurocholic acid (TCA) and dimers and oligomers (please refer to the entire specification particularly the abstract; page 7507; Scheme 1; Figure 1; sections 3.3.2, 3.4.1).
All the claimed elements were known in the prior art (i.e. methods of making hydrogels with bile acid-peptide conjugates) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. formation of a hydrogel) and the combination would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. product) for another (i.e. method of making a hydrogel with the product) would have yielded predictable results (i.e. formation of a hydrogel) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. method of forming a hydrogel with bile acid-peptide conjugates) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sun et al., 2020, The nuclear localization sequence mediates hnRNPA1 amyloid fibril formation revealed by cryoEM structure, Nature Communications, 11: 6349 (8 pages).
Bariya et al., 2021, Recent advances in the bile acid based conjugates/derivatives towards their gelation applications, Steroids, 165: 108769 (13 pages).
Lin et al., 2021, Recent Progress in Bile Acid-Based Antimicrobials, Bioconjugate Chemistry, 32: 395-410.
Kumar et al., 2020, Advances in self-assembled injectable hydrogels for cancer therapy, Biomaterials Science, 8: 2055-2073.
Kumar et al., 2021, Nonimmunogenetic Hydrogel-Mediated Delivery of Antibiotics Outperforms Clinically Used Formulations in Mitigating Wound Infections, ACS Appl Mater & Interfaces, 13: 44041-44053.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
